Consumer medicine information

CERNEVIT I.V

Retinol + Colecalciferol + Alpha tocopheryl acetate + Ascorbic acid + Thiamine + Riboflavine sodium phosphate + Pyridoxine hydrochloride + Cyanocobalamin + Folic acid + Dexpanthenol + Biotin + Nicotinamide

BRAND INFORMATION

Brand name

Cernevit

Active ingredient

Retinol + Colecalciferol + Alpha tocopheryl acetate + Ascorbic acid + Thiamine + Riboflavine sodium phosphate + Pyridoxine hydrochloride + Cyanocobalamin + Folic acid + Dexpanthenol + Biotin + Nicotinamide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using CERNEVIT I.V.

What is in this leaflet?

This leaflet answers some common questions about Cernevit Multivitamin powder for injection.

It does not contain all of the available information. All medicines have risks and benefit. Your doctor has weighed the risks of you using Cernevit against the benefit they expect it will have for you.

It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about being administered this medicine, ask your doctor or pharmacist.

Keep this leaflet; you may need to read it again.

What Cernevit is used for?

This medicine belongs to the vitamins, mineral and other nutritional supplements group of medicines. It is a multivitamin preparation of both water and fat-soluble vitamins (without Vitamin K) stabilised with a mixture of solubilising agent. This medicine is used as a multivitamin supplement corresponding your daily needs and is given as an injection or infusion directly into the vein (intravenously).

Before you are given Cernevit

Cernevit should not be given to you if:

  • You have had an allergic reaction to any of the ingredients of Cernevit listed in the Ingredients section of this leaflet, especially thiamine (Vitamin B1) or soy/protein products. Some of the symptoms of an allergic reaction may include skin rash, peeling of the skin, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing or shortness of breath.
  • You have an impairment with liver function. You are suffering from hyperparathyroidism due to abnormally elevated calcium levels in the blood.
  • The expiry date (EXP) printed on the pack has passed.

You must tell your doctor if:

  • You are allergic to thiamine (Vitamin B1), nicotinamide components of this product, any other medicines, foods, dyes, or preservatives.
  • You have any other health problems including:
    - Kidney disease
    - Active inflammatory bowel disease
    - You are currently receiving additional vitamins from any other sources, especially with Vitamin A, D and E
    - Liver disease
  • You are pregnant or intend to become pregnant, as it is not known whether Cernevit may cause harm to the foetus. Your doctor will discuss with you the risks and benefits of giving this product during pregnancy.
  • You are breast-feeding or wish to breast feed, as it is known that vitamins are excreted in breast milk. Your doctor will discuss with you the risks and benefits of giving Cernevit injection to a nursing mother.
  • You are taking prescription medicines, such as antiepileptic drugs; phenobarbitol, primidone and phenytoin (with brand name Dilantin). The effectiveness of the active component in antiepileptic drugs is affected by folic acid, one of the vitamins included in the Cernevit formulation. Several vitamins can decrease the effectiveness of antibiotics, such as bleomycin and the tetracycline family.
  • You are taking medications containing theophylline, tipranavir or vitamin K antagonists, such as warfarin.
  • You are taking any other medicines including any that you get without a prescription from your pharmacy, supermarket or health food stores, in particular for heart or blood pressure or levodopa for the treatment of Parkinson’s disease.

How is Cernevit given?

How much is given:

Your doctor will decide when and how much Cernevit will be given to you, which depends on your need and condition.

How is it given:

Your doctor will inject the medicine into you. Cernevit injection will be given to you as a slow injection after it has been mixed with drip solutions, directly into the vein (intravenously) by your doctor or trained nurse.

This medicine is for single use and for one person only. Any unused portion must be discarded and not used later, either for you or anyone else.

How long will it be given:

Your doctor will determine the duration of your treatment, which will depend on your need.

Case of overdose

The doctor or nurse giving you Cernevit has had experience in the use of this sort of medicine, so it is unlikely that you will be given an overdose. However, in case of an overdose, the Cernevit treatment will be discontinued and another treatment may be needed. You may experience some of the effects listed under “Side Effects” below.

Side Effects

As with any medicines, some side effects may occur. Allergic reactions have been known to occur following intravenous injection of Vitamin B1.

Always tell your doctor or nurse if you have any unexpected effects during or after receiving Cernevit and they worry you, including:

  • Swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing.
  • Flushing, itching or burning of the skin, sneezing/hives or mild asthma-like attacks.
  • Yellowing of the skin and eyes, also called jaundice.
  • Breathing difficulties
  • Faster heart beat
  • Diarrhea

Storage Conditions

Cernevit should be stored below 25°C and protected from light and heat.

Do not freeze.

Product Description

What Cernevit looks like

Cernevit is presented as an orange-yellow powder contained in a brown glass vial, closed with elastomer closures and crimped by aluminium cap. Each vial is accompanied by ampoule containing 5 mL of water for injection. Your doctor or trained nurse will reconstitute it with the provided water for injection prior to the infusion or injection of your medicine.

Ingredients:

Each vial of Cernevit contains the following components:

Active Ingredients

  • Retinol as retinyl palmitate (3500 IU),
  • cholecalciferol (5.5 μg),
  • dl-alpha-tocopherol (10.20 mg),
  • ascorbic acid (125 mg),
  • cocarboxylase tetrahydrate (5.80 mg),
  • riboflavin sodium phosphate (5.67 mg),
  • pyridoxine hydrochloride (5.50 mg)
  • cyanocobalamin (6 μg),
  • folic acid (414 μg),
  • dexpanthenol (16.15 mg),
  • biotin (69 μg),
  • nicotinamide (46 mg).

Other ingredients

Glycine, glycocholic acid, lecithin, sodium hydroxide and/or hydrochloric acid.

Name and Address of Sponsor

Baxter Healthcare Pty Ltd.
1 Baxter Drive,
Old Toongabbie, NSW 2146,
Australia

Australian Registration number
AUST R 92418

Date of preparation:
March 2016

Cernevit and Baxter are trademarks of Baxter International Inc

Published by MIMS May 2017

BRAND INFORMATION

Brand name

Cernevit

Active ingredient

Retinol + Colecalciferol + Alpha tocopheryl acetate + Ascorbic acid + Thiamine + Riboflavine sodium phosphate + Pyridoxine hydrochloride + Cyanocobalamin + Folic acid + Dexpanthenol + Biotin + Nicotinamide

Schedule

S4

 

1 Name of Medicine

Retinol palmitate, colecalciferol, dl-alpha-tocopherol, ascorbic acid, cocarboxylase tetrahydrate, riboflavine sodium phosphate, pyridoxine hydrochloride, cyanocobalamin, folic acid, dexpanthenol, biotin and nicotinamide.

2 Qualitative and Quantitative Composition

Cernevit is a multivitamin preparation, lyophilised, sterile powder, for reconstitution in 5 mL of Water for Injections or other compatible parenteral fluids.
Content of lyophilisate in each vial (see Table 1).
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/CERNEV01.gif Excipients. Glycine 250 mg, Glycocholic acid 140 mg, Lecithin 112.5 mg, (Lecithin [Soybean] 112.5 mg), Sodium hydroxide 10% qs and/or, 1 M hydrochloric acid qs pH 5.9.
The active ingredients in Cernevit are water-soluble and fat-soluble vitamins, which are well characterised. The Glycine component is included in the formulation as an excipient in order to facilitate the reconstitution of the lyophilised product with Water for Injection.

3 Pharmaceutical Form

Cernevit is a sterile dosage form for intravenous injection or infusion containing nine water-soluble and three fat-soluble vitamins (vitamin K is not included in Cernevit), using mixed micelles (glycocholic acid and lecithin) as a solubilising agent. It is presented as a lyophilised, orange-yellow, sterile powder. That is to be reconstituted with 5 mL of water for injections or other parenteral fluids, (e.g. as 0.9% sodium chloride, 5% glucose or nutritional mixtures), prior to administration by parenteral route.

4 Clinical Particulars

4.9 Overdose

There is little data concerning the overdosage of Cernevit.
Acute or chronic overdose of vitamins (in particular A, B6, D, and E) can cause symptomatic hypervitaminosis.
The risk of overdose is particularly high if a patient receives vitamins from multiple sources and overall supplementation of a vitamin does not match the patient's individual requirements, and in patients with increased susceptibility to hypervitaminosis.
The signs of overdose of Cernevit are mostly those resulting from administration of excessive doses of vitamin A.
Clinical signs of acute overdose of vitamin A (doses exceeding 150,000 IU): gastrointestinal disorders, headache, raised intracranial pressure, papilloedema, psychiatric disorders, irritability, or even convulsions, delayed generalised desquamation.
Clinical signs of chronic intoxication (prolonged vitamin A supplementation with supraphysiological doses in nondeficient subjects): raised intracranial pressure, cortical hyperostosis of long bones and premature epiphyseal fusion. The diagnosis is generally based on the presence of tender or painful subcutaneous swellings in the extremities of the limbs. X-rays demonstrate diaphyseal periosteal thickening of the ulna, fibula, clavicles and ribs.
Action to be taken in the event of acute or chronic overdose: stop administration of Cernevit, reduce calcium intake, increase diuresis and rehydrate. Hypercalcaemia occurs as a result of vitamin D hypervitaminosis. Symptoms of hypercalcaemia include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdose can lead to vascular and organ calcification.
Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of calcium and vitamin D and rehydration.
In cases of suspected overdose, symptomatic and supportive therapy should be instituted as appropriate, and further administration of the product discontinued.
Given the doses of these vitamins contained in Cernevit, it is unlikely that, used as directed, toxicity would occur, however, care must be taken if patients are receiving any additional supplementation from other sources.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No mutagenicity studies have been performed with Cernevit. In a single test for mutagenicity in bacteria, heat-degraded mixed micelles, a solubilising agent in the product, were not mutagenic.
Carcinogenicity. No carcinogenicity studies have been performed with Cernevit.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

See Table 2.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/CERNEV02.gif Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSASCACI.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBIOTIN.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCOCARB.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCOLECA.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCYANOB.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDEXPAN.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSALTOCO.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFOLICA.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSNICAMI.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPYRHYD.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSRETPAL.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSRIBSOP.gif CAS number. Ascorbic acid: 50-81-7.
Biotin: 58-85-5.
Cocarboxylase tetrahydrate: 68684-55-9.
Colecalciferol: 67-97-0.
Cyanocobalamin: 68-19-9.
Dexpanthenol: 81-13-0.
Dl-alpha-tocopherol: 10191-41-0.
Folic acid: 59-30-3.
Nicotinamide: 98-92-0.
Pyridoxine hydrochloride: 58-56-0.
Retinol palmitate: 79-81-2.
Riboflavine sodium phosphate: 130-40-5.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/CERNEVST.gif